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510(k) Data Aggregation

    K Number
    K192148
    Device Name
    Freedom Primary PCK
    Manufacturer
    Maxx Orthopedics, Inc.
    Date Cleared
    2019-09-05

    (28 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Freedom Primary PCK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Freedom® Primary PCK is designed to be used with the Freedom® Stemmed Tibial Components and as a part of the Freedom® Total Knee System, and is indicated for the following:

    · Severe knee joint pain, loss of mobility due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

    · Correction of functional deformities.

    · Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.

    • · Moderate valgus, varus, or flexion trauma.
    • · Knee fractures untreatable by other methods

    · Revision surgery where sufficient bone stock and soft tissue integrity are present

    The Freedom® Primary PCK is intended for cemented use only. This device is for single use only.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) clearance letter for the "Freedom Primary PCK" knee prosthesis does not contain any information about acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML medical device.

    The document is a clearance letter for a physical medical device (a knee implant) and focuses on regulatory aspects like substantial equivalence to predicate devices, general controls, and indications for use. It does not mention any AI/ML components, performance metrics, or clinical study data related to an AI/ML algorithm.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication methods.
    5. MRMC comparative effectiveness study results.
    6. Standalone performance.
    7. Type of ground truth used.
    8. Training set sample size.
    9. Ground truth establishment for the training set.

    These details are typically found in the clinical study report or performance evaluation section of a submission for an AI/ML-driven device, which is not present in this regulatory clearance letter for a knee implant.

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